Value of Intermediate endpoints for Treatment in outpAtient cLinic: Nurse-led multi-factorial risk counselling intervention to improve adherence to lipid lowering medication and lipid levels versus routine clinical care in patients with an increased cardiovascular risk

Nurse-led multi-factorial risk counselling intervention to improve adherence to lipid lowering medication and lipid levels versus routine clinical care in patients with an increased cardiovascular risk: a randomised non-blinded two-centre controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01369334

Enrollment

200

Registered

2011-11-02

Start date

2002-05-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease Circulatory System Other heart disorders in diseases classified elsewhere

Interventions

Patients were randomly assigned to receive routine care or extended care at baseline and at months 3, 9 and 18. Patients in the extended care group received a personalized risk factor passport, showin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Indication for statin therapy 2. Age >18 years 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Use of statin therapy > 3 months 2. Diabetus mellitus type II: fasting glucose >7,0 mmol/L 3. Fasting total cholesterol > 9,0 mmol/L 4. Fasting Triglycerides > 4,0 mmol/L 5. Liver function disturbances (ASAT/ALAT >2 times reference values) 6. Creatinine kinase (CK) elevations (>3 times reference values) 7. Drug and/or alcohol abuse 8. Pregnancy and breastfeeding 9. Life expectancy <2 years 10. Inability to fill out a Dutch questionnaire, because of problems with Dutch language

Design outcomes

Primary

Measure	Time frame
1. Lipid levels: total cholesterol, triglycerides, higher-density-lipid cholesterol, and lower-density-lipid cholesterol 2. Adherence to lipid lowering medication in the past week (scale from 1 to 5), and in the past month (scale from 1 to 9) 3. Anxiety, assessed by the Hospital Anxiety and Depression Scale Assessed at baseline and at months 3, 9 and 18.	—

Secondary

Measure	Time frame
1. Carotid intima-media thickness 2. Flow-mediated dilatation 3. Body Mass Index 4. Quality of Life (SF-12) 5. Symptoms (symptom checklist EORTC) 6. Beliefs about Medication Questionnaire (BMQ) 7. Risk perception (scale from 1 to 9) 8. Self-reported smoking status (yes/no) 9. Blood pressure, systolic and diastolic. Carotid intima-media thickness and flow-mediated dilatation are assessed at baseline and at month 18. The other secondary outcomes are assessed at baseline and at months 3, 9 and 18.	—

Measure

Time frame

1. Carotid intima-media thickness 2. Flow-mediated dilatation 3. Body Mass Index 4. Quality of Life (SF-12) 5. Symptoms (symptom checklist EORTC) 6. Beliefs about Medication Questionnaire (BMQ) 7. Risk perception (scale from 1 to 9) 8. Self-reported smoking status (yes/no) 9. Blood pressure, systolic and diastolic. Carotid intima-media thickness and flow-mediated dilatation are assessed at baseline and at month 18. The other secondary outcomes are assessed at baseline and at months 3, 9 and 18.

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026